Angioplasty and Stenting for Renal Artery Lesions - ASTRAL

Description:

The goal of this trial was to evaluate percutaneous renal artery revascularization compared with medical therapy in patients with significant renal artery stenosis.

Hypothesis:

Percutaneous revascularization of stenotic renal arteries would be more effective at decreasing the rate of decline in renal function.

Study Design

  • Randomized
  • Parallel

Patients Enrolled: 806
Mean Follow Up: 27 months
Mean Patient Age: 70 years
Female: 37

Patient Populations:

  • Clinical suspicion for atherosclerotic renal disease, with substantial anatomical atherosclerotic stenosis in at least one renal artery

Exclusions:

  • Need for surgical revascularization
  • High likelihood of needing revascularization within 6 months
  • Nonatheromatous cardiovascular disease
  • History of prior revascularization for renal artery stenosis

Primary Endpoints:

  • Change in renal function

Secondary Endpoints:

  • Blood pressure control
  • Time to first renal event
  • Time to first cardiovascular event
  • Mortality

Drug/Procedures Used:

Patients with significant renal artery stenosis were randomized to percutaneous renal artery revascularization (angioplasty and/or stenting) plus medical therapy (n = 403) or medical therapy alone (n = 403).

Concomitant Medications:

For the two groups at baseline, renal revascularization versus continued medical management, use of the following medications was: diuretics 70% versus 67%, calcium antagonists 61% versus 68%, beta-blockers 46% versus 52%, angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers 47% versus 38%, alpha-blockers 39% versus 37%, aspirin 91% versus 93%, and statins 96% versus 95%, respectively.

Principal Findings:

At baseline for the entire group, serum creatinine was 179 µmol/L (2.02 mg/dl), estimated glomerular filtration rate was 40 ml/min, mean stenosis was 76%, mean number of antihypertensive medications was 2.8 per patient, and blood pressure was 151/76 mm Hg. Also, there were 53% ex-smokers, 30% diabetics, and 41% with a history of peripheral vascular disease. There were 6% of the medically treated patients that crossed over to renal revascularization and 82% of the revascularization group that were successfully revascularized (95% of revascularized patients received a stent).

Overall mortality was 25.6% in the revascularization group, as compared with 26.3% in the medically treated groups (p = 0.46). Cardiovascular mortality occurred in 7.4% of the revascularization group and 8.2% of the medically treated group (p = NS). Any CV event occurred in 35% of patients in the revascularization group, as compared with 36% in the medically treated group (p = 0.96). Hospitalization for fluid overload or heart failure occurred in 12% of the revascularization group and 14% of the medically treated group (p = NS). There was no difference in serum creatinine, systolic blood pressure, time to first renal event, or overall vascular event during follow-up (p = NS for all outcomes).

Interpretation:

Currently, there is no evidence of benefit for renal artery revascularization. Specifically, renal revascularization did not improve serum creatinine, systolic blood pressure, renal events (such as acute renal failure or dialysis), mortality, or overall vascular events. It remains to be determined if renal revascularization would benefit certain subgroups such as patients with acute renal failure with a critical renal artery stenosis or those who present with flash pulmonary edema.

References:

The ASTRAL Investigators. Revascularization versus medical therapy for renal-artery stenosis. N Engl J Med 2009;361:1953-62.

The Impact of Renal Artery Revascularisation in Atherosclerotic Renovascular Disease: The Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) Trial. Presented by Dr. Philip Kalra at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.

Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Acute Heart Failure, Interventions and Vascular Medicine

Keywords: Pulmonary Edema, Follow-Up Studies, Kidney Function Tests, Acute Kidney Injury, Blood Pressure, Constriction, Pathologic, Creatinine, Angioplasty, Peripheral Vascular Diseases, Stents, Renal Dialysis, Renal Artery Obstruction, Heart Failure, Glomerular Filtration Rate, Hospitalization, Diabetes Mellitus


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